FDA Presents Results of Comprehensive Study on Lasik Quality of Life Project

By
 
Lance Kugler, MD, president,
Refractive Surgery Alliance.
CHICAGO—Results reported by the Food & Drug Administration (FDA) on a long-awaited comprehensive prospective, multi-center study on the safety and efficacy of Lasik were well-received by refractive surgeons in attendance at the recent American Academy of Ophthalmology (AAO) meeting held in Chicago, according to eye surgeon Lance Kugler, MD, president of the Refractive Surgery Alliance.

The study surveyed patients regarding their visual symptoms and quality of life before and three months after Lasik surgery. The FDA report confirms that over 95 percent of the survey respondents achieved 20/20 or better binocular vision. The study also indicated that the prevalence of symptoms such as ghosting, glare, halos and starburst did not increase post operatively after Lasik. “In fact, patients with ghosting actually decreased from 33 percent before surgery to 6 percent after surgery,” said Dr. Kugler.

“This report will provide reassurance to potential Lasik patients who may be hesitant to have their vision corrected due to fear or concerns about safety or results. We’re obviously extremely pleased with the favorable results reported by the FDA in the extensive study,” said Dr. Kugler, who indicated this was the most comprehensive study of patient-reported outcomes after Lasik ever conducted.

Malvina B. Eydelman, MD, director, division of ophthalmic device evaluation, FDA, reported the results as part of the Lasik Quality of Life Collaboration Project (LQOLCP), a partnership with the Department of Defense (DOD) and the National Eye Institute (NEI), incorporating data from questionnaires PROWL-1 and PROWL-2 (Patient reported outcomes with Lasik).

“The Refractive Surgery Alliance (RSA) is grateful to the FDA, NIH, and DOD for conducting this comprehensive study,” said Dr. Kugler. “The data confirm what patients and their refractive surgeons have known for many years: That Lasik is a safe and effective treatment for the correction of myopia, hyperopia and astigmatism.”

Incoming RSA president, Greg Parkhurst, MD, said his colleagues will use this data to continue refining laser vision correction techniques. “Our goal with Lasik is to continually enhance our pre-operative diagnostics and surgical techniques to provide patients a higher quality of vision than is possible with corrective eyewear,” he said. “The Refractive Surgery Alliance puts high value on studies of Lasik outcomes. We will continue to address the small percentage of patients who are not fully satisfied with their outcomes.”

Approximately 16 million Lasik procedures have been performed in the U.S. over the past two decades. “The collective experience of the RSA surgeon members suggests that results continue to improve beyond three months,” said Dr. Kugler. “Satisfaction is expected to be even higher over time. By six months, the vast majority of dry eye symptoms, i.e. feeling dryness, foreign body sensation and night-vision difficulty, will abate.”

Kugler cautioned that “Occasional complications can occur after Lasik. Fortunately, most are transient. The RSA and many Lasik surgeons around the world are continually striving to make the results better and to eliminate all complications. This report confirms that those efforts are having an impact.”

The Refractive Surgery Alliance (RSA) is a professional organization formed in early 2014 by leading refractive surgeons from the U.S. and Europe. It is member supported and does not accept industry or corporate funds. The mission of the RSA is to increase access to refractive surgery through education, research and industry leadership. Membership is open to all qualified refractive surgeons.